BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- bisoprolol fumarate and hydrochlorothiazide tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

제공처:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

BISOPROLOL FUMARATE

구성:

BISOPROLOL FUMARATE 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension. Bisoprolol fumarate and hydrochlorothiazide tablets are contraindicated in patients in cardiogenic shock, overt cardiac failure (see WARNINGS), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.

제품 요약:

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are available in the following strengths: 10 mg/6.25 mg. The 10 mg/6.25 mg tablets are white, film-coated, round, unscored tablets debossed with 505 on one side of the tablet and M on the other side. They are available as follows: NDC 43063-134-30 bottles of 30 tablets NDC 43063-134-90 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
DESCRIPTION
Bisoprolol fumarate and hydrochlorothiazide tablets, USP are indicated
for the treatment of
hypertension. It combines two antihypertensive agents in a once-daily
dosage: a synthetic beta
-
selective (cardioselective) adrenoceptor blocking agent (bisoprolol
fumarate) and a benzothiadiazine
diuretic (hydrochlorothiazide).
Bisoprolol fumarate is chemically described as
(±)-1-[[α-(2-Isopropoxyethoxy)-p-toly]oxy]-3-
(isopropylamino)-2-propanol fumarate (2:1) (salt). It possesses an
asymmetric carbon atom in its
structure and is provided as a racemic mixture. The S(-) enantiomer is
responsible for most of the beta-
blocking activity. Its molecular formula is (C
H
NO
)
•C
H
O
and it has a molecular weight of
766.97. Its structural formula is:
Bisoprolol fumarate, USP is a white crystalline powder, approximately
equally hydrophilic and
lipophilic, and readily soluble in water, methanol, ethanol, and
chloroform.
Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2
_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-
dioxide. It is a white, or practically white, practically odorless
crystalline powder. It is slightly soluble
in water, sparingly soluble in dilute sodium hydroxide solution,
freely soluble in n-butylamine and
dimethylformamide, sparingly soluble in methanol, and insoluble in
ether, chloroform, and dilute mineral
acids. Its molecular formula is C
H
ClN
O
S
and it has a molecular weight of 297.73. Its structural
formula is:
Each bisoprolol fumarate and hydrochlorothiazide tablet, for oral
administration, contains one of the
following combinations of bisoprolol fumarate/hydrochlorothiazide: 2.5
mg/6.25 mg, 5 mg/6.25 mg or
10 mg/6.25 mg. Each tablet also contains the following inactive
ingredients: anhydrous lactose,
colloidal silicon dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline
cellulose, polydextrose, polyethylene glyco